TOPAMAX 25MG TABLETS

Transcript

609 LEAFLET Topamax 20160121

PACKAGE LEAFLET: INFORMATION FOR THE USER

TOPAMAX 25mg TABLETS
(topiramate)

Topamax with food and drink
You can take Topamax with or without food. Drink plenty of fluids
during the day to prevent kidney stones while taking Topamax. You
should avoid drinking alcohol when taking Topamax.
Pregnancy and breast-feeding

The name of your medicine is Topamax 25mg Tablets but will be
referred to as Topamax throughout the following leaflet.
Please note that information regarding other strengths 50mg,
100mg and 200mg of Topamax Tablets may also be present in the
below leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
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Keep this leaflet. You may need to read it again

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If you have any further questions, ask your doctor or pharmacist

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This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours

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If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet

If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor for advice before
taking this medicine.
Your doctor will discuss use of contraceptives with you, as well as
discussing whether Topamax is suitable for you. As with other antiepileptic medicines, there is a risk of harm to the unborn child if
Topamax is used during pregnancy. Make sure you are very clear
about the risks and the benefits of using Topamax for epilepsy
during pregnancy.
You should not take Topamax for migraine prevention if you are
pregnant or you are able to become pregnant and you are not using
effective contraception.
Mothers who breast-feed while taking Topamax must tell the doctor
as soon as possible if the baby experiences anything unusual.
Driving and using machines
Dizziness, tiredness and vision problems may occur during
treatment with Topamax. Do not drive or use any tools or machines
without talking to your doctor first.

1

What Topamax is and what it is used for

2

What you need to know before you take Topamax

Topamax contains lactose

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How to take Topamax

4

Possible side effects

5

How to store Topamax

If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product.

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Contents of the pack and other information
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1

WHAT TOPAMAX IS AND WHAT IT IS USED FOR

Topamax belongs to a group of medicines called “antiepileptic
medicines.” It is used:
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alone to treat seizures in adults and children over age 6

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with other medicines to treat seizures in adults and children
aged 2 years and above

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to prevent migraine headaches in adults

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WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TOPAMAX

Do not take Topamax
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if you are allergic to topiramate or any of the other ingredients
of this medicine (listed in section 6)

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for migraine prevention if you are pregnant, or you are able to
become pregnant but you are not using effective contraception
(see section ‘pregnancy and breast-feeding’ for further
information)

If you are not sure if the above applies to you, talk to your doctor or
pharmacist before using Topamax.
Warnings and precautions
Talk to your doctor or pharmacist before taking Topamax if you:
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have a history of blood and body fluid abnormality (metabolic
acidosis)

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have liver problems

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have eye problems, especially glaucoma

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have a growth problem

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are on a high fat diet (ketogenic diet)

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are pregnant or could become pregnant (see section
‘pregnancy and breast-feeding’ for further information)

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Topamax.
It is important that you do not stop taking your medicine without first
consulting your doctor.
You should also talk to your doctor before taking any medicine
containing topiramate that is given to you as an alternative to
Topamax.
You may lose weight if you use Topamax so your weight should be
checked regularly when using this medicine. If you are losing too
much weight or a child using this medicine is not gaining enough
weight, you should consult your doctor.
A small number of people being treated with antiepileptic medicines
such as Topamax have had thoughts of harming or killing
themselves. If at any time you have these thoughts, immediately
contact your doctor.
Other medicines and Topamax
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. Topamax and certain other
medicines can affect each other. Sometimes the dose of some of
your other medicines or Topamax will have to be adjusted.

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
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Your doctor will usually start you on a low dose of Topamax and
slowly increase your dose until the best dose is found for you

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Topamax tablets are to be swallowed whole. Avoid chewing the
tablets as they may leave a bitter taste

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Topamax can be taken before, during, or after a meal. Drink
plenty of fluids during the day to prevent kidney stones while
taking Topamax

If you take more Topamax than you should
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See a doctor right away. Take the medicine pack with you

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You may feel sleepy, tired, or less alert; lack coordination; have
difficulty speaking or concentrating, have double or blurred
vision; feel dizzy due to low blood pressure; feel depressed or
agitated; or have abdominal pain, or seizures (fits)

Overdose can happen if you are taking other medicines together
with Topamax.
If you forget to take Topamax
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If you forget to take a dose, take it as soon as you remember it.
However, if it is almost time for your next dose, skip the missed
dose and continue as usual. If you miss two or more doses,
contact your doctor

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Do not take a double dose (two doses at the same time) to
make up for a forgotten dose

If you stop taking Topamax
Do not stop taking this medicine unless told to do so by your doctor.
Your symptoms may return. If your doctor decides to stop this
medication, your dose may be decreased gradually over a few
days.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
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other medicines that impair or decrease your thinking,
concentration, or muscle coordination (e.g., central nervous
system depressant medicines such as muscle relaxants and
sedatives)
birth control pills. Topamax may make your birth control pills
less effective

Tell your doctor if your menstrual bleeding changes while you are
taking birth control pills and Topamax.
Keep a list of all the medicines you take. Show this list to your
doctor and pharmacist before you start a new medicine.
Other medicines you should discuss with your doctor or pharmacist
include other antiepileptic medicines, risperidone, lithium,
hydrochlorothiazide, metformin, pioglitazone, glyburide,
amitriptyline, propranolol, diltiazem, venlafaxine, flunarazine,
St. John’s wort (Hypericum perforatum) (a herbal preparation used
to treat depression).
If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Topamax.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Tell your doctor, or seek medical attention immediately if you
have the following side effects:
Very common (may affect more than 1 in 10 people)
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Other side effects that may occur in children are:
Common (may affect up to 1 in 10 people)

• Weight gain
Uncommon (may affect up to 1 in 100 people)

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Sensation of spinning (vertigo)

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Vomiting

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Fever

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Decrease in platelets (blood cells that help stop bleeding),
decrease in white blood cells that help to protect you against
infection, decrease in potassium level in the blood
Increase in liver enzymes, increase in eosinophils (a type of
white blood cell) in the blood

Uncommon (may affect up to 1 in 100 people)
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Increase in eosinophils (a type of white blood cell) in the blood

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Hyperactivity

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Swollen glands in the neck, armpit, or groin

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Feeling warm

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Increased appetite

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Learning disability

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Elevated mood

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Hearing, seeing, or feeling things that are not there, severe
mental disorder (psychosis)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on
the safety of this medicine.
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HOW TO STORE TOPAMAX

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KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

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Do not store your tablets above 25°C.

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Keep the bottle tightly closed. Store in the original package to
protect from moisture.

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Do not use Topamax Tablets after the expiry date which is
stated on the carton, bottle and blister strip. The expiry date
refers to the last day of that month.

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Tablets should not be thrown in your bin or put down the drain.
If they are out of date, or no longer suitable for you, return them
to your pharmacist.

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If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.